South Korean firm sues Dr Reddy's in US court

Mezzion Pharma accuses Dr Reddy's of fraud by hiding significant deficiencies in CGMP regulations

Seoul-based biotech company Mezzion Pharma has filed a suit against Dr Reddy’s Laboratories (DRL) in a US court. It has alleged the Hyderabad-based supplier had committed fraud by hiding significant deficiencies in the Current Good Manufacturing Practice, or CGMP, regulations enforced by the US health regulator. 

In the suit, filed in the state of New Jersey, Mezzion seeks to “recover millions of dollars from DRL in damages for fraudulent concealment and misrepresenting its compliance”. It alleges the misconduct was “the sole reason given by the US Food and Drug Administration (FDA) to deny approval” of Mezzion’s new drug application (NDA)